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A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05428033
Recruitment Status : Active, not recruiting
First Posted : June 22, 2022
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description
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Brief Summary:
This trial will be conducted to evaluate the efficacy of centanafadine QD XR versus placebo in the treatment of child subjects (4 to 12 years, inclusive) with ADHD. The trial will consist of a screening period, a double-blind treatment period, and follow-up period.

Condition or disease Intervention/treatment Phase
Attention Deficit/Hyperactivity Disorder Drug: centanafadine capsule Other: placebo capsule Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
Actual Study Start Date : July 11, 2022
Estimated Primary Completion Date : October 13, 2023
Estimated Study Completion Date : October 20, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Weight Based High Dose Centanafadine Capsules
High dose - weight-based dosing
 Drug: centanafadine capsule
capsule
Other Names:
  • centanafadine
  • centanafadine XR
  • EB-1020
Experimental: Weight Based Low Dose Centanafadine Capsules
Low dose - weight-based dosing
 Drug: centanafadine capsule
capsule
Other Names:
  • centanafadine
  • centanafadine XR
  • EB-1020
Placebo Comparator: Matching Placebo
Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color.
 Other: placebo capsule
capsule
Other Names:
  • placebo comparator
  • matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6 [ Time Frame: From baseline to week 6 ]

Secondary Outcome Measures :
  1. Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) change from baseline in CGI-S-ADHD at Week 6 [ Time Frame: From baseline to week 6 ]
  2. Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6 [ Time Frame: From baseline to week 6 ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 4 to 12 years (inclusive) at the time of informed consent/assent.
  • A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with the MINI-KID.
  • A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline for all subjects.
  • A score of 4 or higher on the CGI-S-ADHD at baseline.
  • Subjects aged 4 or 5 years only: has failed adequate psychotherapy or in the investigator's opinion, is severe enough to require pharmacotherapy in the absence of prior psychotherapy.

Exclusion Criteria:

  • Comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder that is severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Oppositional Defiant Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or MDD with current major depressive episode.
  • A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. A history of suicidal behavior (over the last 6 months).
  • BMI ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on US CDC criteria.
  • Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05428033


Locations
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United States, New York
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 10012
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT05428033    
Other Study ID Numbers: 405-201-00021
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
URL: https://clinical-trials.otsuka.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Centanafadine
ADHD
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases